ARCADIA

• Research type

  Research Study

• Full title

  Phase II proof of concept study of Abatacept (Orencia) in individuals who aRe Considered At risk of Developing Inflammatory Arthritis

• IRAS ID

  189403

• Contact name

  Prof. Paul Emery

• Contact email

  p.emery@leeds.ac.uk

• Sponsor organisation

  The University of Leeds

• Eudract number

  2015-005285-38

• Duration of Study in the UK

  4 years, 0 months, 1 days

• Research summary

  Rheumatoid arthritis (RA) is an autoimmune disease that causes inflammation in your joints. The main symptoms are joint pain and swelling. In RA, your own immune system causes an immune reaction (this includes the production of antibodies) that may cause inflammation in joint tissues. Over time, the inflammation can damage the joint, specifically causing destruction of cartilage and bone. In some patients, the inflammation can affect other organs such as blood vessels, the eyes or lungs. If not adequately treated, the condition may lead to permanent damage to joints, disability, affecting quality of life.
  Evidence from early clinical trials suggests that the immunological disease process starts many years before the onset of clinically detectable inflammatory arthritis. There is also evidence that has shown that early intensive treatment with biological drugs such as abatacept has the potential to reduce symptoms and slow down or even stop further joint damage, and potentially prevent the onset of RA.

  Abatacept has been shown to be effective in established rheumatoid arthritis but the purpose of the trial is to test a licensed drug called abatacept to see if it can delay the onset of inflammatory arthritis in patients who are deemed to be at-risk of developing inflammatory and rheumatoid arthritis, before they actually get it. We would like to see how well this treatment works and what effects it has on the immune system.

  ARCADIA is a cohort randomized control trial which means that individuals will be randomly allocated to receive either weekly injections of abatacept (Arm A) or continue with standard of care treatment (Arm B) for 1 year and then being followed up for an additional 1 year. This provides the best chance of establishing whether differences observed between the two groups are due to the treatment.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  17/YH/0173

• Date of REC Opinion

  21 Jul 2017

• REC opinion

  Further Information Favourable Opinion